Data Management and Digitalisation in Regulatory Affairs

Data Management and Digitalisation in Regulatory Affairs
This Masterclass will provide you with  the theoretical background to data management, document management, electronic submissions, eCompliance regulatory information management and the new identification of Medicinal Products (IDMP) requirements, and find solutions to practical problems in this area. Deal with large volumes of data and deal with different data (from nonclinical to post-market pharmacovigilance).  This is also Module 12 of the TOPRA MSc Regulatory Affairs.


When: 20–22 November 2019
Where: Lincoln Plaza Hotel, London, UK
Start time: Day 1 - 14:00
End time: Day 3 - 15:30

Course overview

Regulatory affairs has always involved dealing with large quantities of data, from nonclinical data to post-market pharmacovigilance. The complexity of the analysis is increasing.
This course will cover:
  • data management in daily RA work
  • digitilisation
  • EMA telematics strategy
  • eCTD
  • EMA's collaboration and strategy
  • archiving of RA documents
  • CSV
  • regulatory information and management
  • regulatory intelligence and knowledge management
  • IDMP
  • big data approaches to regulatory affairs

Benefits to delegates

This course will enable you to:

  • Explain the importance of data, document and information management
  • Demonstrate a critical understanding of the processes and requirements necessary for completing an eCTD
  • Critically evaluate the IDMP requirements
  • Identify issues with electronic compliance
  • Make recommendations about regulatory information management and IDMP strategies
  • Critically analyse data and documentation strategies and processes
  • Critically appraise regulatory processes and documentation
CPD: This course provides 19 CPD hours upon successful completion

To learn more about why Continuing Professional Development is important, visit our Lifelong Learning page.


Will be available closer to the event date.


TOPRA Masterclasses are developed and delivered by a faculty  of expert speakers from relevant industry, agencies, notified bodies and other stakeholders and are validated by the University of Hertfordshire.

Suitable for

  • Students of the TOPRA MSc programme
  • Delegates from the medical device industry who wish to develop their knowledge
  • Delegates from allied industries who wish to have a comprehensive understanding of the subject


    Course fees:
    Type Student Delegate
    Standard    £1500 + VAT £1700 + VAT 

    Discounted places
    A limited number of discounted places are available  for those working for regulatory or government agencies, academic institutions, charities, patient groups or in full time education at the rates below. 
    Please email us at for a discount code before making your booking.

    Those working for regulatory agencies, government agencies or academic institutions 
     £1275 + VAT
    Those working for charities, patient groups or in full-time education
       £1275 + VAT

    • VAT, if applicable, is charged at the VAT rate of 20% 
    • The registration fee does not include accommodation 
    • Refreshments and lunch are included in the registration fee

    Terms and conditions

    Please read the training terms and conditions before booking this course. By booking a place on this course you are agreeing to the training terms and conditions

    20/11/2019 - 22/11/2019
    Lincoln Plaza Hotel 2 Lincoln Plaza London E14 9BD UNITED KINGDOM
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    Recording and photography by delegates is not permitted.